Cleared Traditional

K163125 - geko T-2 and geko Plus R-2 Neuromuscula...

K163125 is an FDA 510(k) clearance for geko T-2 and geko Plus R-2 Neuromuscula..., manufactured by Firstkind Limited. The device is a Class 2 Physical Medicine device with product code IPF cleared through the Traditional 510(k) pathway after a 153-day FDA review.

K163125 · Firstkind Limited · Physical Medicine device
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Apr 2017
Decision
153d
Days
Class 2
Risk

K163125 is an FDA 510(k) clearance for the geko™ T-2 and geko™ Plus R-2 Neuromuscular Stimulators. Classified as Stimulator, Muscle, Powered (product code IPF), Class II - Special Controls.

Submitted by Firstkind Limited (High Wycombe, GB). The FDA issued a Cleared decision on April 10, 2017 after a review of 153 days - an extended review cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5850 - the FDA physical medicine device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Physical Medicine review framework, consistent with the majority of Class II 510(k) submissions.

View all Firstkind Limited devices

FDA 510(k) Submission Details - K163125

510(k) Number K163125 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 08, 2016
Decision Date April 10, 2017
Days to Decision 153 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
38d slower than avg
Panel avg: 115d · This submission: 153d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

IPF Device Classification - Class 2, Special Controls

Product Code IPF Stimulator, Muscle, Powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.5850
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Physical Medicine devices follow this clearance model.

Regulatory Peers - IPF Stimulator, Muscle, Powered

All 166
Devices cleared under the same product code (IPF) and FDA review panel - the closest regulatory comparables to K163125.
Digitimer DS7AP Constant Current Stimulator
K172381 · Digitimer , Ltd. · Mar 2018
geko T-2 and geko Plus R-2
K180082 · Firstkind, Ltd. · Feb 2018
Combo Stimulator MT9000, Combo Stimulator LT7102, TENS Stimulator InTENSity 10
K171978 · Shenzhen Dongdixin Technology Co., Ltd. · Oct 2017
HPM-6000
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SYS*STIM 240
K113017 · Mettler Electronics Corp. · Jun 2012
EMPI CONTINUUM
K093324 · Empi · Mar 2010